Just as a friendly reminder the that potential pivotal PDD and AVATER trials turned out not to be pivotal.
Very unlikely imo that the P2b/3 trial will be pivotal since it couldn’t report straightforward TLR showing pivotal potential. There may be an out chance that the pre-specified subgroup analysis turns up a large enough n with convincing outcomes.
Time will tell but pivotal is not something to bank on based on what is known atm.